FDA flags 10 observations in another Form 483 for a Zydus plant

2024-05-06

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来源: FiercePharma

The FDA visited Zydus' plant in Gujarat, India, last month.

Zydus Lifesciences recently received its second Form 483 reprimand from the FDA within the span of one month. In the second write-up, the regulatory agency flagged issues ranging from unqualified employees performing sample collections to improper evaluations of drug batches.

The agency inspected the company’s site in Gujarat, India, between April 15 and April 23, finding ten observations of manufacturing procedural shortfalls. The FDA posted the more recent Form 483 on April 29.

According to the FDA, Zydus’ facility demonstrated inconsistencies with internal investigations, skirted sampling plans and skipped over procedures meant to prevent microbiological contamination of sterile drug products.

Plus, even after an investigation found cross-contamination in rejected batches, other drug lots produced on the same equipment were released to the U.S. without a thorough investigation, the FDA pointed out.

In one example of Zydus' problems with sampling and testing procedures, an employee was reported to be collecting samples despite not actually doing so and instead delegating the task to a staffer who wasn’t qualified, the FDA said.

The FDA also listed its concerns about Zydus' lack of written procedures to ensure products feature the correct strength, purity and quality. The agency further said Zydus' equipment and utensils weren’t regularly cleaned to prevent contamination, among other regulatory concerns.

The latest Form 483 represents the second recent FDA citation for Zydus.

Last month, the agency posted another Form 483 issued after a March inspection of Zydus’ facility in Matoda, India. During that visit, the FDA flagged four observations, including failure to clean and maintain equipment and a lack of procedures to prevent microbiological contamination of sterile products.

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